MRI-Guided Cryoablation for Focal Native Prostate Cancer

Recruiting

• Conditions: Primary Malignant Neoplasm of Prostate (Diagnosis)
• Interventions: Procedure: MR guided cryoablation

• Registration Number: NCT04797039
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed.

Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.

Detailed Description

The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits.

The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
• Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
• Tumor size is < 2 cm at its largest diameter
• Tumor does not encompass the rectal wall or external urethral sphincter
• Patient is able to undergo MRI

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Exclusion Criteria

•

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MR guided cryoablation	MR guided cryoablation	Focal MR guided cryoablation for low- to intermediate-grade prostate cancer

Primary Outcome Measures

Name	Time	Method
Safety of the MR-guided cryoablation	Will assess for 5 years with interval assessment each year	Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure.
Examine short term tumor recurrence	Will assess for 5 years with interval assessment each year	Examine short term tumor recurrence over 6 months with contrast enhanced MRI and as required MR or U/S guided biopsy of prostate bed if PSA biochemical recurrence.
Technical success of the MR-guided cryoablation	Will assess for 5 years with interval assessment each year	Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation.

Secondary Outcome Measures

Name	Time	Method
MR procedure time.	Will assess for 5 years with interval assessment each year	We will examine the time for each step in the process to create a stream-lined process and minimize MR procedure time.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States